Assessment of an Automated Optical Coherence Tomography and Camera : Effectiveness of Vision-700

Assessment of an Automated Optical Coherence Tomography and Camera : Effectiveness o

The objective of study is to assess the repeatability and agreement of the retina and cornea measurement by Vision-700 in comparison with those by 3D OCT-1.

Study Overview

• Status: Completed
• Conditions: Glaucoma; Cornea; Retinal Disease; Normal Subject
• Intervention / Treatment: Device: Vision-700

Detailed Description

The first objective of study is to assess the repeatability and agreement of the retina and cornea measurement by Vision-700 in comparison with those by 3D OCT-1, and Cornea Measurements by RTVue XR + CAM. The second objective is to compare the agreement of fundus photography quality between Vision-700 with 3D OCT-1.

• Study Type: Observational
• Enrollment (Actual): 159

Contacts and Locations

Study Locations

• Taiwan
  • Taipei county, Taiwan
    • Tri-Services General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects, Glaucoma subjects, Retinal diseasse subjects, Cornea condition subjects

Description

Inclusion Criteria:

Subject 22 years old or older on the date of informed consent; Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent.

Normal Group:

(1)Subjects presenting at the site with normal eyes bilaterally (cataracts are acceptable). (2)IOP ≤ 21 mmHg bilaterally; BCVA 20/40 or better bilaterally. (3) No history of corneal, glaucoma, or retinal diseases. (4)No history of ocular surgeries, including laser refractive surgery, cataract surgery, glaucoma surgery and retinal surgery. (5)Subjects without any current ocular pathology other than cataract in the normal eye(s), as determined by self-report and/or investigator assessment at the study visit.

Glaucoma Group:

(1) With a current BCVA of 20/40 or better in the glaucoma study eyes. (2) History of visual field defects within the previous six months from the study visit or measured on the day of the study visit that is consistent with glaucomatous optic nerve damage. (3) Subjects who have been diagnosed with glaucoma in the glaucoma study eyes based on the presence of visual field defects, regardless of the optic nerve head and RNFL appearance. (4) Subjects without retinal disease or cornea condition in the glaucoma study eyes, as determined by self-report and/or investigator assessment at the study visit.

Retinal Disease Group:

(1)Subjects with a current BCVA of 20/400 or better in the retinal disease study eye(s) at the study visit. (2)Subjects diagnosed with retinal pathology including but not limited to any one of following criteria: a. Non Exudative Macular Degeneration (dry AMD), Diabetic Macular Edema, Macular Hole, Epiretinal Membrane, Cystoid Macular Edema, or other retinal disease in the study eye(s) as confirmed within the past six months, who exhibit structural lesions in the study eye; b. Neovascular Macular Degeneration (wet AMD), Diabetic Retinopathy, Retinal Artery Occlusion, Retinal Vein Occlusion or other retinal disease in the study eye(s) as confirmed within the past six months, who exhibit vascular and/or ischemic lesions in the study eye. (3) Subjects without glaucoma or cornea condition in the retinal disease study eye(s), as determined by self-report and/or investigator assessment at the study visit.

Cornea Condition Group:

History of refractive surgery, contact lens (wear contact lens more than 6 months), dry eye or keratoconus.

Exclusion Criteria:

1. Subjects unable to tolerate ophthalmic imaging;
2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
3. Subjects with a history of leukemia, dementia or multiple sclerosis.
4. Subjects with history of hydroxychloroquine or chloroquine use
5. Subjects with photosensitivity
6. Subject having Photodynamic therapy (PDT) within 6 months
7. Subjects taking photosensitivity drug currently
8. Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal Group: (1)Subjects presenting at the site with normal eyes bilaterally (cataracts are acceptable). (2)IOP ≤ 21 mmHg bilaterally; BCVA 20/40 or better bilaterally. (3) No history of corneal, glaucoma, or retinal diseases. (4)No history of ocular surgeries, including laser refractive surgery, cataract surgery, glaucoma surgery and retinal surgery. (5)Subjects without any current ocular pathology other than cataract in the normal eye(s), as determined by self-report and/or investigator assessment at the study visit.	Device: Vision-700; OCT machines used for diagnostic purposes; Other Names: 3D OCT-1 Maestro
Glaucoma Group; (1) With a current BCVA of 20/40 or better in the glaucoma study eyes. (2) History of visual field defects within the previous six months from the study visit or measured on the day of the study visit that is consistent with glaucomatous optic nerve damage. (3) Subjects who have been diagnosed with glaucoma in the glaucoma study eyes based on the presence of visual field defects, regardless of the optic nerve head and RNFL appearance. (4) Subjects without retinal disease or cornea condition in the glaucoma study eyes, as determined by self-report and/or investigator assessment at the study visit.	Device: Vision-700; OCT machines used for diagnostic purposes; Other Names: 3D OCT-1 Maestro
Retinal Disease Group; (1)Subjects with a current BCVA of 20/400 or better in the retinal disease study eye(s) at the study visit. (2)Subjects diagnosed with retinal pathology including but not limited to any one of following criteria: a. Non Exudative Macular Degeneration (dry AMD), Diabetic Macular Edema, Macular Hole, Epiretinal Membrane, Cystoid Macular Edema, or other retinal disease in the study eye(s) as confirmed within the past six months, who exhibit structural lesions in the study eye; b. Neovascular Macular Degeneration (wet AMD), Diabetic Retinopathy, Retinal Artery Occlusion, Retinal Vein Occlusion or other retinal disease in the study eye(s) as confirmed within the past six months, who exhibit vascular and/or ischemic lesions in the study eye. (3) Subjects without glaucoma or cornea condition in the retinal disease study eye(s), as determined by self-report and/or investigator assessment at the study visit.	Device: Vision-700; OCT machines used for diagnostic purposes; Other Names: 3D OCT-1 Maestro
Cornea Condition Group; History of refractive surgery, contact lens (wear contact lens more than 6 months), dry eye or keratoconus.	Device: Vision-700; OCT machines used for diagnostic purposes; Other Names: 3D OCT-1 Maestro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Precision of Vision-700 in Retinal and Cornea Measurement	The Precision included the repeatability and reproducibility.	2022/9/1
The Precision of 3D OCT-1 in Retinal and Cornea Measurements	The Precision included the repeatability and reproducibility.	2022/9/1
The Agreement of Vision-700 and 3D OCT-1 in Retinal and Cornea Measurements	the agreement study	2022/9/1

Collaborators and Investigators

• Sponsor: Crystalvue Medical Coporation
• Investigators: Principal Investigator: I-Chia Liang, Tri-Services General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases
• Other Study ID Numbers: Effectiveness of Vision-700

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No